Changes in Intra-articular Parameters by Doppler Ultrasound in Patients With Hemophilic Ankle Arthropathy

NCT ID: NCT06281340

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2024-04-21

Brief Summary

Introduction: Hemophilic ankle arthropathy is manifested by functional degenerative alterations, intra-articular alterations, and chronic pain. Manual therapy techniques are used in the treatment of hemophilic ankle arthropathy for the improvement of pain and mobility.

Design. Double-blind randomized pilot trial. Aimed: To evaluate the ultrasound changes by means of Doppler imaging after manual therapy intervention.

Patients: A total of 20 adult patients with hemophilic ankle arthropathy will be recruited.

Intervention: Each manual therapy session will last approximately 50 minutes, with 1 session per week for a period of 3 weeks. The treatment program includes 10 techniques that will be administered bilaterally.

Measuring instruments: Patients will be evaluated qualitatively with ultrasound (HEAD-US scale) and assessment with Doppler ultrasound. The clinical variables will be joint damage (Hemophilia Joint Health Score) and pain intensity (Visual Analogue Scale).

Expected results: Check the safety of manual therapy in patients with hemophilia regarding subclinical bleeding. Assess changes related to joint inflammatory state with imaging techniques. Observe changes in pain intensity and joint damage.

Conditions

Hemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

The patients included in the experimental group will receive a session of manual physiotherapy using joint gliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints. The intervention will be performed on both ankles.

Group Type: EXPERIMENTAL

Manual therapy

Intervention Type: OTHER

Each session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy.

Control group

Patients included in the control group will receive a placebo manual physical therapy session, simulating joint sliding techniques, myofascial and manipulative techniques of the tobioperoneoastotalar and subtalar joints, without any stimulus other than the pressure exerted by the physical therapist with his hands when mobilizing the foot. The placebo intervention will be performed on both ankles.

Group Type: PLACEBO_COMPARATOR

Placebo manual therapy

Intervention Type: OTHER

Each session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle.

Interventions

Manual therapy

Each session will last approximately 50-60 minutes. Each session is composed of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to the criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy.

Intervention Type: OTHER

Placebo manual therapy

Each session will last approximately 50-60 minutes. Each session consists of the placebo application of 10 techniques, 9 of which correspond to manual interventions commonly used in the field of manual therapy and adapted to patients with hemophilic arthropathy, according to criteria previously established in studies that assess the safety of manual interventions in hemophilic arthropathy. In the techniques there will be no joint sliding, manipulations or myofascial inductions, being the only stimulus the contact of the physiotherapist with his hands and the pressure exerted with these, on the ankle.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with hemophilia A or B.
• Persons over 18 years of age.
• Patients with a medical diagnosis of ankle arthropathy (with clinical assessment of more than 4 points on the Hemophilia Joint Health Score.
• Patients on prophylactic or on-demand treatment with FVIII / FIX concentrates.
• Sign the informed consent document.

Exclusion Criteria

• Patients with inhibitors (antibodies against FVIII or FIX) without treatment with monoclonal antibodies.
• Patients with neurological or cognitive alterations that impede the comprehension of questionnaires and physical tests.
• Patients who have developed an ankle hemarthrosis in the 3 months prior to the study.
• Patients who at the time of the study are receiving ankle physiotherapy treatment.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Investigación en Hemofilia y Fisioterapia

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rubén Cuesta-Barriuso, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad de Oviedo

Locations

University of Oviedo

Oviedo, Principality of Asturias, Spain

Countries

Spain

Other Identifiers

He-ankle US

Identifier Type: -

Identifier Source: org_study_id